| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01009-1 |
| Product Name/Description |
Brilliance CT Big Bore with Software Versions 2.4.7 or 2.4.8 (Full body CT system)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare has received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem can occur when the scan was in "Ready to Scan" or scanning mode. There is a risk of undesired radiation due to the potential for a rescan if this issue happened during scanning mode. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare will be installing a software update to address the identified issue. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |